Use of Remote Monitoring for COVID-19 Patient

Not Applicable

Completed

Conditions: COVID

Interventions: Device: LifeSignals Biosensor 1AX*
Other: Standard of Care

Registration Number: NCT04425720

Lead Sponsor: Montefiore Medical Center

Brief Summary: The central hypothesis motivating this study is that remote patient monitoring (RPM) of infectious disease patients can efficiently facilitate self-isolation. Additionally, RPM can assist in more rapid identification of patients at risk, facilitate detection of patient deterioration, and enable early interventions, all of which play a vital role in resource utilization and outcomes.

Detailed Description: Aim-I To develop and test a clinical care pathway that can be utilized in similar epidemic conditions in the future. To study this aim, the investigators will be using the COVID-19 medical surge as a condition to evaluate the framework of delivering care through remote patient monitoring. The success of this care delivery model will be evaluated on ease of model implementation, patient satisfaction, clinical outcomes, and the utilization of shared decision making.

Aim-II To evaluate remote patient monitoring for appropriate resource utilization in epidemic and pandemic conditions. To evaluate this aim, the investigators plan to compare the emergency department (ED) visits and in-patient admission of patients with and without wearable remote patient monitoring devices. Additionally, the investigators will compare the number of patients that required critical interventions (mechanical ventilation and ECMO) during the hospital stay.

Aim III To evaluate the utilization of wearable technology for upfront predictions of patients that would require in-patient admissions. To evaluate this aim, patients who are diagnosed with COVID-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary. The comparison group will be patients undergoing routine standard of care at the hospital. ED visits, in-patient hospital admissions, and patient satisfaction will be the outcome measures compared between the two groups.

Aim IV To evaluate the association between early identification of critical, abnormal vital signs and the prevention of serious adverse events. To evaluate this aim, patients in the monitored group and non-monitored group will be compared for ED visits, in-patient admissions, length of hospital stay, and serious adverse events.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 300

Inclusion Criteria

Covid-19 positive patient
Does not require in-patient admission

Exclusion Criteria

Allergic to sensor patch
Has implanted pacemaker
Has excessive sweating

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monitored	LifeSignals Biosensor 1AX*	Patients who are diagnosed with COVID-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary
Standard Of Care	Standard of Care	Patients without wearable monitoring technology undergoing routine standard of care at the hospital.

Primary Outcome Measures

Name	Time	Method
Number of Monitored Versus Non-Monitored In-patient Admission	14 days	compare the number of in-patient admissions between the monitored and non-monitored patients
How Many Subjects Needed to Visit the Emergency Department	14 days	compare the number of participants who visited Emergency Department between both arms
Length of Stay	14 days	Length of stay of subject if hospitalized
How Many Completed the Patient Satisfaction Survey	14 days	Survey given to patients who were monitored to ask about satisfaction with the program. A research associate calls enrolled subjects to determine their opinions having participated in the program.
How Many Subjects End up Requiring Mechanical Ventilation and ECMO	14 days	How often does a subject end up getting mechanical ventilation or ECMO
Serious Adverse Events	14 days	events requiring extended hospital stay